QUALIFICATION & VALIDATION SPECIALIST
Department: QA
is a biotechnology company whose mission is to develop biologic products for the imaging and treatment of life‑threatening diseases, with a special focus on angiogenesis-related disorders.
Philogen S.p.A. would like to hire a Qualification & Validation Specialist to join the Quality Unit.
Preparing and verifying qualification and validation documents;
Drafting thermal validation study protocols and reports;
Drafting, verifying and executing qualification protocols and tests, including FAT, SAT, IOQ and PQ;
Performing validation test runs and related activities;
Drafting and monitoring VMP activities;
Supporting qualification activities for equipment and utilities, e.g. HVAC systems, water systems and process gases;
Supporting the Maintenance Department with calibration and maintenance plans and instructions;
A degree in Engineering,



Chemistry, Biotechnology, Pharmaceutical Chemistry and Technology, or a related field;
A minimum of 3–4 years of experience in the pharmaceutical industry;
Knowledge of GMP;
Knowledge of the main methodologies for the risk-based approach, such as FMEA, HACCP, etc.;
Knowledge of the main validation/calibration instruments: thermal validation loggers, data acquisition systems, calibration instruments, etc.;
An annual salary package ranging from €35,000 to €45,000, depending on experience and profile.
We invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003.

📌 Validation specialist. (Italia)
🏢 Biotecnologie - Farmacia - Chimica
📍 Italia